Note from the National Guideline Clearinghouse: This guideline references a drug(s) for which important revised regulatory and/or warning information has been released.

March 9, 2015 – Chantix and Varenicline: The U.S. Food and Drug Administration (FDA) is warning that the prescription smoking cessation medicine Chantix (varenicline) can change the way people react to alcohol. Interactions between alcohol and Chantix have resulted in some patients experiencing increased intoxicating effects of alcohol, sometimes associated with aggressive behavior and/or amnesia. In addition, rare accounts of seizures in patients treated with Chantix have been reported. FDA has approved changes to the Chantix label to warn about these risks. Refer to the Drug Safety Communication for a detailed data summary.

To offer best practice advice on the identification and care of patients with chronic obstructive pulmonary disease (COPD)

To define the symptoms, signs, and investigations required to establish a diagnosis of COPD

To define the factors that are necessary to assess its severity, provide prognostic information, and guide best management

To give guidance on the pharmacological and non-pharmacological treatment of patients with stable COPD, and on the management of exacerbations

To discuss the interface with surgery and intensive therapy units (ITU)

Update Aim

The aim of the National Collaborating Centre for Acute and Chronic Conditions (NCC-ACC) is to provide a user-friendly, clinical, evidence-based guideline for the National Health Service (NHS) in England and Wales that:

Offers best clinical advice for the management and treatment of COPD in adults in primary and secondary care

Is based on best published clinical and economics evidence, alongside expert interpretation

Takes into account patient choice and informed decision-making

Defines the major components of NHS care provision for COPD

Details areas of uncertainty or controversy requiring further research

Provides a choice of guideline versions for different audiences

Target Population

Adults who have a clinical working diagnosis of chronic obstructive pulmonary disease (COPD)

Methodology

Hand-searches of Published Literature (Primary Sources)Hand-searches of Published Literature (Secondary Sources)Searches of Electronic Databases

Description of Methods Used to Collect/Select the Evidence

Note from the National Guideline Clearinghouse (NGC): This guideline was developed by the National Clinical Guideline Centre for Acute and Chronic Conditions (NCGC-ACC) on behalf of the National Institute for Health and Clinical Excellence (NICE). See the "Availability of Companion Documents" field for the full version of this guidance.

Searching for the Evidence

The Information Scientist developed a search strategy for each question. Key words for the search were identified by the Guideline Development Group (GDG). A separate health economic search strategy was developed looking for economic studies in chronic obstructive pulmonary disease (COPD). Papers that were published in peer-reviewed journals (including e-publications ahead print where identified) were considered as evidence by the GDG. Conference paper abstracts and non-English language papers were excluded from the searches. Where it was deemed appropriate and where there was lack of evidence in the literature on an area of clinical importance, the GDG decided to initiate a 'call for evidence' asking all registered stakeholders to submit any relevant unpublished evidence. Where this occurred this is detailed within the guideline write-up.

Each clinical question dictated the appropriate study design that was prioritised in the search strategy but the strategy was not limited solely to these study types. The research fellow or health economist identified relevant titles and abstracts for each clinical question from the search results and full papers were obtained. Exclusion lists were generated for each question together with the rationale for the exclusion. The exclusion lists were presented to the GDG. See appendices I and J in the full version of the actual guideline for review protocols and literature search details.

Literature Search

Limited details of the searches with regard to databases and constraints applied can be found in Appendix A of the original guideline document (full version). In general, no formal contact was made with authors of identified studies, but occasionally it was necessary to contact authors for clarification of specific points. Additional contemporary articles were identified by the Guideline Development Group on an ad hoc basis. Stakeholder evidence identified via a process established by the National Institute for Clinical Excellence was incorporated where appropriate. Both were assessed for inclusion by the same criteria as evidence provided by the electronic searches.

Searches were re-run at the end of the guideline development process, thus including evidence published up to the end of May 2003. Studies recommended by stakeholders or Guideline Development Group members that were published after this date were not considered for inclusion. This time-point should be the starting point for searching for new evidence for future updates to this guideline.

Re-run Evidence

Literature searches were repeated for all of the evidence based questions at the end of the GDG development process allowing any relevant papers published up until 20th August 2009 to be considered. Future guideline updates will consider evidence published after this cut-off date. Further updates will take place in concordance with the specifications outlined in the NICE guidelines manual.

Literature Search for Economic Evidence

Priority areas for new health economics modelling were agreed by the GDG after the formation of the clinical questions and consideration of available health economic evidence. The Health Economist performed supplemental literature searches to obtain additional data for modelling. Assumptions, data and structures of the models were explained to and agreed by the GDG members during meetings, and they commented on subsequent revisions. See appendix M in the full version of the guideline for details of the modelling undertaken for the guideline.

NICE: Evidence from National Institute for Health and Clinical Excellence (NICE) guidelines or Health Technology Appraisal program

HSC: Evidence from Health Service Circulars

Methods Used to Analyze the Evidence

Review of Published Meta-AnalysesSystematic Review with Evidence Tables

Description of the Methods Used to Analyze the Evidence

Note from the National Guideline Clearinghouse (NGC): This guideline was developed by the National Clinical Guideline Centre for Acute and Chronic Conditions (NCGC-ACC) on behalf of the National Institute for Health and Clinical Excellence (NICE). See the "Availability of Companion Documents" field for the full version of this guidance.

Distilling and Synthesizing the Evidence

The evidence from each full paper was distilled into an evidence table and synthesized into an evidence profile and evidence statements before being presented to the Guideline Development Group (GDG). The results of health economic modelling undertaken for the guideline were also presented to the GDG. This evidence was then reviewed by the GDG and used as a basis upon which to formulate recommendations. Evidence tables are available at http://guidance.nice.org.uk/CG101/EvidenceTables/pdf/English.

Appraising the Evidence

The research fellow or health economist, as appropriate, critically appraised the full papers. In general, no formal contact was made with authors. However there were ad hoc occasions when this was required in order to clarify specific details. Critical appraisal checklists were compiled for each full paper.

For non-observational studies, where possible this included meta-analysis of data and synthesis of data into a GRADE 'evidence profile'. The evidence profile shows for each outcome an overall assessment of both the quality of the evidence as a whole (low, moderate or high), as well as an estimate of the size of effect. For observational and qualitative studies, a narrative summary (evidence statements) was written summarising the results.

For economic studies, an economic 'evidence profile' was constructed. The economic evidence profile shows, for each economic study, an assessment of applicability (directly applicable, partially applicable or not applicable) and methodological quality (minor limitations, potentially serious limitations, very serious limitations) with footnotes indicating the reasons for the assessment. It also shows incremental costs, incremental outcomes (e.g., QALYs) and the incremental cost-effectiveness ratio from the primary analysis, as well as information about the assessment of uncertainty in the analysis. In this guideline results are presented for the comparison specified in the clinical question irrespective of whether or not the comparison was 'appropriate' in the analysis being reviewed (that is where an intervention is compared with the next most expensive non-dominated option – a clinical strategy is said to 'dominate' the alternatives when it is both more effective and less costly). Footnotes indicated if a comparison was 'inappropriate' in the analysis.

A research fellow or health economist, as appropriate, undertook the critical appraisal and data extraction. The evidence was considered carefully by the GDG for accuracy and completeness.

All procedures are fully compliant with the NICE methodology as detailed in the 'Guideline Development Methods – Information for National Collaborating Centres and Guideline Developers' Manual.

Methods Used to Formulate the Recommendations

Expert Consensus

Description of Methods Used to Formulate the Recommendations

Note from the National Guideline Clearinghouse (NGC): This guideline was developed by the National Clinical Guideline Centre for Acute and Chronic Conditions (NCGC-ACC) on behalf of the National Institute for Health and Clinical Excellence (NICE). See the "Availability of Companion Documents" field for the full version of this guidance.

The National Clinical Guidelines Centre for Acute and Chronic Conditions (NCGC-ACC) was set up in 2009 and is housed within the Royal College of Physicians (RCP). The NCGC-ACC undertakes commissions received from the National Institute for Health and Clinical Excellence (NICE).

The technical team met approximately two weeks before each Guideline Development Group (GDG) meeting and comprised the following members: GDG Chair, GDG Clinical Advisor, Information Scientist, Research Fellow, Health Economist and Project Manager.

The GDG met monthly and comprised a multi-disciplinary team of health professionals and a person with chronic obstructive pulmonary disease (COPD), who were supported by the technical team. The GDG membership details including patient representation and professional groups are detailed in the GDG membership table at the front of this guideline.

Guideline Project Executive (PE) was involved in overseeing all phases of the guideline. It also reviewed the quality of the guideline and compliance with the Department of Health (DH) remit and NICE scope. The PE comprised of: NCGC-ACC Clinical Director; NCGC-ACC Operations Director; NICE Commissioning Manager; Technical Team.

At the end of the guideline development process, the GDG met to review and agree the guideline recommendations.

Involvement of people with COPD

The NCGC-ACC was keen to ensure the views and preferences of people with COPD and their carers informed all stages of the guideline. This was achieved by:

Having a person with COPD as a patient representative on the guideline development group (GDG)

Consulting with the Patient and Public Involvement Programme (PPIP) housed within NICE during the pre-development (scoping) and final validation stages of the guideline.

Inclusion of patient groups as registered stakeholders for the guideline.

Securing patient organization representation from the British Lung Foundation on the guideline development group.

Approve recommendations based on lesser evidence or extrapolations from other situations

Reach consensus recommendations where the evidence was inadequate

Debate areas of disagreement and finalize recommendations

The GDG also reached agreement on the following:

Recommendations as key priorities for implementation

Future research recommendations

Algorithms

In prioritizing key priorities for implementation, the GDG took into account the following criteria:

High clinical impact

High impact on reducing variation in practice

More efficient use of National Health Service (NHS) resources

Allowing the patient to reach critical points in the care pathway more quickly

Writing the Guideline

The first draft version of the guideline was drawn up by the technical team in accordance with the decisions of the GDG, incorporating contributions from individual GDG members in their expert areas and edited for consistency of style and terminology. The guideline was then submitted for a formal public and stakeholder consultation prior to publication. The registered stakeholders for this guideline are detailed on the NICE website www.nice.org.uk. Editorial responsibility for the full guideline rests with the GDG.

Rating Scheme for the Strength of the Recommendations

Not applicable

Cost Analysis

Undertaking New Health Economic Analysis

Priority areas for new health economics modelling were agreed by the Guideline Development Group (GDG) after the formation of the clinical questions and consideration of available health economic evidence. The Health Economist performed supplemental literature searches to obtain additional data for modelling. Assumptions, data and structures of the models were explained to and agreed by the GDG members during meetings, and they commented on subsequent revisions. See appendix M in the full version of the original guideline for details of the modelling undertaken for the guideline.

Method of Guideline Validation

External Peer ReviewInternal Peer Review

Description of Method of Guideline Validation

The guideline was validated through two consultations.

The first draft of the guideline (the full guideline, National Institute for Clinical Excellence [NICE] guideline and Quick Reference Guide) were consulted with Stakeholders and comments were considered by the Guideline Development Group (GDG).

The final consultation draft of the full guideline, the NICE guideline and the Information for the Public were submitted to stakeholders for final comments.

The final draft was submitted to the Guideline Review Panel for review prior to publication.

Recommendations

Major Recommendations

Note from the National Guideline Clearinghouse (NGC): This guideline was developed by the National Clinical Guideline Centre for Acute and Chronic Conditions (NCGC-ACC) on behalf of the National Institute for Health and Clinical Excellence (NICE). See the "Availability of Companion Documents" field for the full version of this guidance.

Unlike the original guideline, recommendations made in this partial update are no longer graded on the strength of evidence, in keeping with the guidelines manual 2009.

Diagnosing Chronic Obstructive Pulmonary Disease (COPD)

The diagnosis of COPD depends on thinking of it as a cause of breathlessness or cough. The diagnosis is suspected on the basis of symptoms and signs and supported by spirometry.

Symptoms

A diagnosis of COPD should be considered in patients over the age of 35 who have a risk factor (generally smoking) and who present with one or more of the following symptoms:

Exertional breathlessness

Chronic cough

Regular sputum production

Frequent winter "bronchitis"

Wheeze [2004]

Patients in whom a diagnosis of COPD is considered should also be asked about the presence of the following factors:

Weight loss

Effort intolerance

Waking at night

Ankle swelling

Fatigue

Occupational hazards

Chest pain

Hemoptysis

Note: These last two symptoms are uncommon in COPD and raise the possibility of an alternative diagnosis. [2004]

One of the primary symptoms of COPD is breathlessness. The Medical Research Council (MRC) dyspnea scale (see Table 1 below) should be used to grade the breathlessness according to the level of exertion required to elicit it. [2004]

Table 1. MRC Dyspnea Scale

Grade

Degree of Breathlessness Related to Activities

1

Not troubled by breathlessness except on strenuous exercise

2

Short of breath when hurrying or walking up a slight hill

3

Walks slower than contemporaries on level ground because of breathlessness or has to stop for breath when walking at own pace

4

Stops for breath after walking about 100 meters or after a few minutes on level ground

5

Too breathless to leave the house or breathless when dressing or undressing

Adapted from Fletcher CM, Elmes PC, Fairbairn MB et al. (1959) the significance of respiratory symptoms and the diagnosis of chronic bronchitis in a working population. British Medical Journal 2:257-66.

Spirometry

Spirometry should be performed:

At the time of diagnosis

To reconsider the diagnosis if patients show an exceptionally good response to treatment. [2004]

Older people without typical symptoms of COPD where the FEV1/FVC ratio is < 0.7

Younger people with symptoms of COPD where the FEV1/FVC ratio is ≥0.7. [new 2010]

All health professionals involved in the care of people with COPD should have access to spirometry and be competent in the interpretation of the results. [2004]

Spirometry can be performed by any health-care worker who has undergone appropriate training and who keeps his or her skills up to date. [2004]

Spirometry services should be supported by quality control processes. [2004]

It is recommended that European Respiratory Society (ERS) 1993 reference values are used but it is recognized that these values may lead to under-diagnosis in older people and are not applicable in black and Asian populations. [2004]

Further Investigations

At the time of their initial diagnostic evaluation, in addition to spirometry all patients should have:

A chest radiograph to exclude other pathologies

A full blood count to identify anaemia or polycythaemia

Body mass index (BMI) calculated [2004]

Additional investigations should be performed to aid management in some circumstances (see Table 2 below and in the original guideline document [full version]). [2004]

Table 2. Additional Investigations

Investigation

Role

Serial domiciliary peak flow measurements

To exclude asthma if diagnostic doubt remains

Alpha-1 antitrypsin

If early onset, minimal smoking history, or family history

Transfer factor for carbon monoxide (TLCO)

To investigate symptoms that seem disproportionate to the spirometric impairment

Computed tomography (CT) scan of the thorax

To investigate symptoms that seem disproportionate to the spirometric impairment

To investigate abnormalities seen on a chest radiograph

To assess suitability for surgery

Electrocardiography (ECG)

To assess cardiac status if features of cor pulmonale

Echocardiogram

To assess cardiac status if features of cor pulmonale

Pulse oximetry

To assess need for oxygen therapy; if cyanosis or cor pulmonale present, or if forced expiratory volume in 1 second (FEV1) < 50% predicted

Sputum culture

To identify organisms if sputum is persistently present and purulent

Patients identified as having alpha-1 antitrypsin deficiency should be offered the opportunity to be referred to a specialist centre to discuss the clinical management of this condition. [2004]

Reversibility Testing

In most patients, routine spirometric reversibility testing is not necessary as a part of the diagnostic process or to plan initial therapy with bronchodilators or corticosteroids. It may be unhelpful or misleading because:

Repeated FEV1 measurements can show small spontaneous fluctuations.

The results of a reversibility test performed on different occasions can be inconsistent and not reproducible.

Over-reliance on a single reversibility test may be misleading unless the change in FEV1 is greater than 400 ml.

The definition of the magnitude of a significant change is purely arbitrary.

Response to long-term therapy is not predicted by acute reversibility testing.[2004]

COPD and asthma are frequently distinguishable on the basis of history (and examination) in untreated patients presenting for the first time. Features from the history and examination should be used to differentiate COPD from asthma whenever possible. (See Table 3 below and in the original guideline document [full version] [2004]).

Table 3. Clinical Features Differentiating COPD and Asthma

COPD

Asthma

Smoker or ex-smoker

Nearly all

Possibly

Symptoms under age 35

Rare

Often

Chronic productive cough

Common

Uncommon

Breathlessness

Persistent and progressive

Variable

Night time waking with breathlessness and/or wheeze

Uncommon

Common

Significant diurnal or day-to-day variability of symptoms

Uncommon

Common

Longitudinal observation of patients (whether using spirometry, peak flow, or symptoms) should also be used to help differentiate COPD from asthma. [2004]

To help resolve cases where diagnostic doubt remains, or both COPD and asthma are present, the following findings should be used to help identify asthma:

A large (greater than 400 ml) response to bronchodilators

A large (greater than 400 ml) response to 30 mg oral prednisolone daily for 2 weeks

Clinically significant COPD is not present if the FEV1 and FEV1/forced vital capacity (FVC) ratio return to normal with drug therapy. [2004]

If diagnostic uncertainty remains, referral for more detailed investigations, including imaging and measurement of TLCO, should be considered. [2004]

If patients report a marked improvement in symptoms in response to inhaled therapy, the diagnosis of COPD should be reconsidered.

Assessment of Severity and Prognostic Factors

COPD is heterogeneous, so no single measure can give an adequate assessment of the true severity of the disease in an individual patient. Severity assessment is, nevertheless, important because it has implications for therapy and relates to prognosis.

Be aware that disability in COPD can be poorly reflected in the FEV1. A more comprehensive assessment of severity includes the degree of airflow obstruction and disability, the frequency of exacerbations and the following known prognostic factors:

FEV1

TLCO

Breathlessness (MRC scale)

Health status

Exercise capacity (for example, 6-minute walk test)

Body mass index (BMI)

Partial pressure of oxygen in arterial blood (PaO2)

Cor pulmonale

Calculate the BODE index (BMI, airflow obstruction, dyspnoea and exercise capacity) to assess prognosis where its component information is currently available. [new 2010]

Assessment and Classification of Severity of Airflow Obstruction

The severity of airflow obstruction should be assessed according to the reduction in FEV1 as shown in Table 4. [new 2010]

Table 4. Gradation of Severity of Airflow Obstruction

NICE clinical guideline 12 (2004)

American Thoracic Society (ATS)/ERS 2004

Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2008

NICE clinical guideline 101 (2010)

Postbronchodilator FEV1/FVC

FEV1 % Predicted

Severity of Airflow Obstruction

Postbronchodilator

Postbronchodilator

Postbronchodilator

<0.7

≥80%

Mild

Stage 1–Mild

Stage 1–Mild*

<0.7

50–79%

Mild

Moderate

Stage 2–Moderate

Stage 2–Moderate

<0.7

30–49%

Moderate

Severe

Stage 3–Severe

Stage 3–Severe

<0.7

<30%

Severe

Very severe

Stage 4–Very severe**

Stage 4–Very severe**

*Symptoms should be present to diagnose COPD in people with mild airflow obstruction (see recommendation Diagnosing COPD, Symptoms above).

**Or FEV1 <50% with respiratory failure.

Identification of Early Disease

Spirometry should be performed in patients who are over 35, current or ex-smokers, and have a chronic cough. [2004]

Spirometry should be considered in patients with chronic bronchitis. A significant proportion of these will go on to develop airflow limitation. [2004]

Referral for Specialist Advice

It is recommended that referrals for specialist advice are made when clinically indicated. Referral may be appropriate at all stages of the disease and not solely in the most severely disabled patients. (See Table 5 below and in the original guideline document [full version]). [2004]

Look for other explanations including cardiac impairment, pulmonary hypertension, depression and hyperventilation

Frequent infections

Exclude bronchiectasis

Haemoptysis

Exclude carcinoma of the bronchus

Patients who are referred do not always have to be seen by a respiratory physician. In some cases they may be seen by members of the COPD team who have appropriate training and expertise. [2004]

Managing Stable COPD

Smoking Cessation

An up-to-date smoking history, including pack years smoked (number of cigarettes smoked per day, divided by 20, multiplied by the number of years smoked), should be documented for everyone with COPD. [2004]

All COPD patents still smoking, regardless of age, should be encouraged to stop, and offered help to do so, at every opportunity. [2004]

Short-acting bronchodilators, as necessary, should be the initial empirical treatment for the relief of breathlessness and exercise limitation. [2004]

Inhaled Corticosteroids

Oral corticosteroid reversibility tests do not predict response to inhaled corticosteroid therapy and should not be used to identify which patients should be prescribed inhaled corticosteroids. [2004]

Be aware of the potential risk of developing side effects (including non-fatal pneumonia) in people with COPD treated with inhaled corticosteroids and be prepared to discuss with patients. [new 2010]

Inhaled Combination Therapy

This section provides recommendations on the sequence of inhaled therapies for people with stable COPD. These recommendations are also given in diagram form in algorithm 2a (see appendix C in the full version of the original guideline).

The effectiveness of bronchodilator therapy should not be assessed by lung function alone but should include a variety of other measures such as improvement in symptoms, activities of daily living, exercise capacity, and rapidity of symptom relief. [2004]

Offer once-daily long-acting muscarinic antagonist (LAMA) in preference to four-times-daily short-acting muscarinic antagonist (SAMA) to people with stable COPD who remain breathless or have exacerbations despite using short-acting bronchodilators as required, and in whom a decision has been made to commence regular maintenance bronchodilator therapy with a muscarinic antagonist (The British national formulary states that a SAMA should be discontinued when a LAMA is started). [new 2010]

In people with stable COPD who remain breathless or have exacerbations despite using short-acting bronchodilators as required, offer the following as maintenance therapy:

If FEV1 ≥50% predicted: either long-acting beta2-agonist (LABA) or LAMA

If FEV1 <50% predicted: either LABA with an inhaled corticosteroid (ICS) in a combination inhaler, or LAMA. [new 2010]

In people with stable COPD and an FEV1 ≥50% who remain breathless or have exacerbations despite maintenance therapy with a LABA:

Consider LABA+ICS in a combination inhaler

Consider LAMA in addition to LABA where ICS is declined or not tolerated. [new 2010]

Offer LAMA in addition to LABA+ICS to people with COPD who remain breathless or have exacerbations despite taking LABA+ICS, irrespective of their FEV1. [new 2010]

Consider LABA+ICS in a combination inhaler in addition to LAMA for people with stable COPD who remain breathless or have exacerbations despite maintenance therapy with LAMA irrespective of their FEV1. [new 2010]

The choice of drug(s) should take into account the person's symptomatic response and preference, and the drug's potential to reduce exacerbations, its side effects and cost. [2010]

Delivery Systems Used to Treat Patients with Stable COPD

Most patients – whatever their age – are able to acquire and maintain adequate inhaler technique given adequate instruction. The exception to this is that those with significant cognitive impairment (as a guideline, those with a Hodkinson Abbreviated Mental Test Score of 4 or less) are unable to use any form of inhaler device. In most patients, however, a pragmatic approach guided by individual patient assessment is needed in choosing a device.

Inhalers

In most cases bronchodilator therapy is best administered using a hand-held inhaler device (including a spacer device if appropriate). [2004]

If the patient is unable to use a particular device satisfactorily, it is not suitable for him or her, and an alternative should be found. [2004]

Inhalers should be prescribed only after patients have received training in the use of the device and have demonstrated satisfactory technique. [2004]

Patients should have their ability to use an inhaler device regularly assessed by a competent healthcare professional and, if necessary, should be re-taught the correct technique. [2004]

Spacers

The spacer should be compatible with the patient's metered-dose inhaler. [2004]

It is recommended that spacers are used in the following way:

The drug is administered by repeated single actuations of the metered dose inhaler into the spacer, with each followed by inhalation.

There should be minimal delay between inhaler actuation and inhalation.

Tidal breathing can be used as it is as effective as single breaths. [2004]

Spacers should be cleaned no more than monthly, as more frequent cleaning affects their performance (because of a build-up of static). They should be cleaned with water and washing-up liquid and allowed to air dry. The mouthpiece should be wiped clean of detergent before use. [2004]

Nebulisers

Patients with distressing or disabling breathlessness despite maximal therapy using inhalers should be considered for nebuliser therapy. [2004]

Nebulised therapy should not continue to be prescribed without assessing and confirming that one or more of the following occurs:

A reduction in symptoms

An increase in the ability to undertake activities of daily living

An increase in exercise capacity

An improvement in lung function. [2004]

Nebulised therapy should not be prescribed without an assessment of the patient's and/or carer's ability to use it. [2004]

A nebuliser system that is known to be efficient should be used. Once available, Comité Européen de Normalisation (European Committee for Standardisation, CEN) data should be used to assess efficiency. [2004]

Patients should be offered a choice between a facemask and a mouthpiece to administer their nebulised therapy, unless the drug specifically requires a mouthpiece (for example, anticholinergic drugs). [2004]

If nebuliser therapy is prescribed, the patient should be provided with equipment, servicing, advice, and support. [2004]

Oral Therapy

Oral Corticosteroids

Maintenance use of oral corticosteroid therapy in COPD is not normally recommended. Some patients with advanced COPD may require maintenance oral corticosteroids when these cannot be withdrawn following an exacerbation. In these cases, the dose of oral corticosteroids should be kept as low as possible. [2004]

Patients treated with long-term oral corticosteroid therapy should be monitored for the development of osteoporosis and given appropriate prophylaxis. Patients over the age of 65 should be started on prophylactic treatment, without monitoring. [2004]

Oral Theophylline

In this section of the guideline, the term theophylline is used to mean slow-release formulations of this drug.

Theophylline should only be used after a trial of short-acting bronchodilators and long-acting bronchodilators, or in patients who are unable to use inhaled therapy, as there is a need to monitor plasma levels and interactions. [2004]

Particular caution needs to be taken with the use of theophylline in older people because of differences in pharmacokinetics, the increased likelihood of comorbidities, and the use of other medications. [2004]

The effectiveness of the treatment with theophylline should be assessed by improvements in symptoms, activities of daily living, exercise capacity, and lung function. [2004]

The dose of theophylline prescribed should be reduced at the time of an exacerbation if macrolide or fluoroquinolone antibiotics (or other drugs known to interact) are prescribed. [2004]

Oral Mucolytic Therapy

Mucolytic drug therapy should be considered in patients with a chronic cough productive of sputum. [2004]

Mucolytic therapy should be continued if there is symptomatic improvement (for example, reduction in frequency of cough and sputum production). [2004]

Do not routinely use mucolytic drugs to prevent exacerbations in people with stable COPD. [new 2010]

Oral Anti-oxidant Therapy

Treatment with alpha-tocopherol and beta-carotene supplements, alone or in combination, is not recommended. [2004]

Anti-tussive Therapy

Anti-tussive therapy should not be used in the management of stable COPD. [2004]

Oral Prophylactic Antibiotic Therapy

There is insufficient evidence to recommend prophylactic antibiotic therapy in the management of stable COPD. [2004]

Combined Oral and Inhaled Therapy

If patients remain symptomatic on monotherapy, their treatment should be intensified by combining therapies from different drug classes. Effective combinations include:

Beta2-agonist and theophylline

Anticholinergic and theophylline. [2004]

Oxygen

Long-term Oxygen Therapy (LTOT)

Clinicians should be aware that inappropriate oxygen therapy in people with COPD may cause respiratory depression. [2004]

LTOT is indicated in patients with COPD who have a PaO2 less than 7.3 kPa when stable or a PaO2 greater than 7.3 and less than 8 kPa when stable and one of: secondary polycythaemia, nocturnal hypoxaemia (oxygen saturation of arterial blood [SaO2] less than 90% for more than 30% of time), peripheral oedema, or pulmonary hypertension. [2004]

To get the benefits of LTOT patients should breathe supplemental oxygen for at least 15 hours per day. Greater benefits are seen in patients receiving oxygen for 20 hours per day. [2004]

The need for oxygen therapy should be assessed in:

All patients with severe airflow obstruction (FEV1 less than 30% predicted)

Patients with cyanosis

Patients with polycythaemia

Patients with peripheral oedema

Patients with a raised jugular venous pressure

Patients with oxygen saturations less than or equal to 92% breathing air

Assessment should also be considered in patients with severe airflow obstruction (FEV1 30-49% predicted). [2004]

To ensure all patients eligible for LTOT are identified, pulse oximetry should be available in all health-care settings. [2004]

The assessment of patients for LTOT should comprise the measurement of arterial blood gasses on two occasions at least 3 weeks apart in patients who have a confident diagnosis of COPD, who are receiving optimum medical management, and whose COPD is stable. [2004]

Patients receiving LTOT should be reviewed at least once per year by practitioners familiar with LTOT, and this review should include pulse oximetry. [2004]

Oxygen concentrators should be used to provide the fixed supply at home for long-term oxygen therapy. [2004]

Patients should be warned about the risks of fire and explosion if they continue to smoke when prescribed oxygen. [2004]

Ambulatory Oxygen Therapy

People who are already on LTOT who wish to continue with oxygen therapy outside the home, and who are prepared to use it, should have ambulatory oxygen prescribed. [2004]

Ambulatory oxygen therapy should be considered in patients who have exercise desaturation, are shown to have an improvement in exercise capacity and/or dyspnoea with oxygen, and have the motivation to use oxygen. [2004]

Ambulatory oxygen therapy is not recommended in COPD if PaO2 is greater than 7.3 kPa and there is no exercise desaturation. [2004]

Ambulatory oxygen therapy should only be prescribed after an appropriate assessment has been performed by a specialist. The purpose of the assessment is to assess the extent of desaturation, the improvement in exercise capacity with supplemental oxygen, and the oxygen flow rate required to correct desaturation. [2004]

Small light-weight cylinders, oxygen-conserving devices, and portable liquid oxygen systems should be available for the treatment of patients with COPD. [2004]

A choice about the nature of equipment prescribed should take account of the hours of ambulatory oxygen use required by the patient and the oxygen flow rate required. [2004]

Short-burst Oxygen Therapy

Short-burst oxygen therapy should only be considered for episodes of severe breathlessness in patients with COPD not relieved by other treatments. [2004]

Short-burst oxygen therapy should only continue to be prescribed if an improvement in breathlessness following therapy has been documented. [2004]

When indicated, short-burst oxygen should be provided from cylinders. [2004]

Noninvasive Ventilation (NIV)

Adequately treated patients with chronic hypercapnic respiratory failure who have required assisted ventilation (whether invasive or noninvasive) during an exacerbation or who are hypercapnic or acidotic on LTOT should be referred to a specialist centre for consideration of long-term NIV. [2004]

Management of Pulmonary Hypertension and Cor Pulmonale

In the context of this guideline, the term 'cor pulmonale' has been adopted to define a clinical condition that is identified and managed on the basis of clinical features. This clinical syndrome of cor pulmonale includes patients who have right heart failure secondary to lung disease and those in whom the primary pathology is retention of salt and water, leading to the development of peripheral oedema.

Diagnosis of Pulmonary Hypertension and Cor Pulmonale

A diagnosis of cor pulmonale should be considered if patients have:

Peripheral oedema

A raised venous pressure

A systolic parasternal heave

A loud pulmonary second heart sound [2004]

It is recommended that the diagnosis of cor pulmonale is made clinically and that this process should involve excluding other causes of peripheral oedema. [2004]

Treatment of Cor Pulmonale

Patients presenting with cor pulmonale should be assessed for the need for long-term oxygen therapy. [2004]

Oedema associated with cor pulmonale can usually be controlled symptomatically with diuretic therapy. [2004]

The following are not recommended for the treatment of cor pulmonale:

Angiotensin-converting enzyme inhibitors

Calcium channel blockers

Alpha-blockers

Digoxin (unless there is atrial fibrillation) [2004]

Pulmonary Rehabilitation

Pulmonary rehabilitation is defined as a multidisciplinary programme of care for patients with chronic respiratory impairment that is individually tailored and designed to optimise each patient's physical and social performance and autonomy.

Pulmonary rehabilitation should be made available to all appropriate patients with COPD including those who have had a recent hospitalisation for an acute exacerbation. [new 2010]

Pulmonary rehabilitation should be offered to all patients who consider themselves functionally disabled by COPD (usually MRC grade 3 and above). Pulmonary rehabilitation is not suitable for patients who are unable to walk, who have unstable angina, or who have had a recent myocardial infarction. [2004]

For pulmonary rehabilitation programmes to be effective, and to improve concordance, they should be held at times that suit patients and in buildings that are easy for patients to get to and have good access for people with disabilities. Places should be available within a reasonable time of referral. [2004]

Pulmonary rehabilitation programmes should include multicomponent, multidisciplinary interventions, which are tailored to the individual patient's needs. The rehabilitation process should incorporate a programme of physical training, disease education, and nutritional, psychological, and behavioural intervention. [2004]

Patients should be made aware of the benefits of pulmonary rehabilitation and the commitment required to gain these. [2004]

Patients who are breathless and have a single large bulla on a computed tomography (CT) scan and an FEV1 less than 50% predicted should be referred for consideration of bullectomy. [2004]

Patients with severe COPD who remain breathless with marked restrictions of their activities of daily living, despite maximal medical therapy (including rehabilitation), should be referred for consideration of lung volume reduction surgery if they meet all of the following criteria:

FEV1 more than 20% predicted

PaCO2 less than 7.3 kPa

Upper lobe predominant emphysema

TLCO more than 20% predicted [2004]

Patients with severe COPD who remain breathless with marked restrictions of their activities of daily living despite maximal medical therapy should be considered for referral for assessment for lung transplantation, bearing in mind comorbidities and local surgical protocols. Considerations include:

Many of these activities may be undertaken in the clinic or in the practice as part of routine care by the practitioner seeing the patient but in certain circumstances the patient may need to be referred to a specialist department, for example, physiotherapy. Multidisciplinary working means breaking down historic demarcation of roles because many of the activities in managing COPD can be undertaken by individuals from different professional backgrounds. Competencies are more important than professional boundaries.

COPD care should be delivered by a multidisciplinary team. [2004]

The following functions should be considered when defining the activity of the multidisciplinary team:

Assessing patients (including performing spirometry and assessing the need for oxygen, the need for aids for daily living, and the appropriateness of delivery systems for inhaled therapy)

If the BMI is abnormal (high or low) or changing over time, the patient should be referred for dietetic advice.

If the BMI is low, patients should also be given nutritional supplements to increase their total calorific intake, and be encouraged to take exercise to augment the effects of nutritional supplementation.

In older patients, attention should also be paid to changes in weight, particularly if the change is more than 3 kg. [2004]

Palliative Care

Opioids should be used when appropriate to palliate breathlessness in patients with end-stage COPD which is unresponsive to other medical therapy. [2004]

Benzodiazepines, tricyclic antidepressants, major tranquillisers, and oxygen should also be used when appropriate for breathlessness in patients with end-stage COPD unresponsive to other medical therapy. [2004]

Patients with end-stage COPD and their family and carers should have access to the full range of services offered by multidisciplinary palliative care teams, including admission to hospices. [2004]

Assessment for Occupational Therapy

Patients should be regularly asked about their ability to undertake activities of daily living and how breathless they become when doing these. [2004]

Clinicians involved in the care of patients with COPD should assess their need for occupational therapy using validated tools. [2004]

Social Services

Patients disabled by COPD should be considered for referral for assessment by a social services department. [2004]

Advice on Travel

All patients on LTOT planning air travel should be assessed in line with the British Thoracic Society (BTS) recommendations (Managing passengers with respiratory disease planning air travel: British Thoracic Society recommendations [2002] Thorax 57(4):289-304). [2004]

All patients with an FEV1 less than 50% predicted who are planning air travel should be assessed in line with the BTS recommendations. [2004]

All patients known to have bullous disease should be warned that they are at a theoretically increased risk of developing a pneumothorax during air travel. [2004]

Advice on Diving

Scuba diving is not recommended for patients with COPD. Advise people with queries to seek specialist advice. [2004]

Education

There are significant differences in the response of patients with COPD and asthma to education programmes. Programmes designed for asthma should not be used in COPD. [2004]

Specific educational packages should be developed for patients with COPD.

Suggested topics for inclusion are listed in Appendix C of the original guideline document (see section 5 for details in the full version of the guideline).

The packages should take account of the different needs of patients at different stages of their disease. [2004]

Patients with moderate and severe COPD should be made aware of the technique of NIV. Its benefits and limitations should be explained so that, if it is ever necessary in the future, they will be aware of these issues. [2004]

Self-management

Patients at risk of having an exacerbation of COPD should be given self-management advice that encourages them to respond promptly to the symptoms of an exacerbation. [2004]

Patients should be encouraged to respond promptly to the symptoms of an exacerbation by:

Starting oral corticosteroid therapy if their increased breathlessness interferes with activities of daily living (unless contraindicated)

Starting antibiotic therapy if their sputum is purulent

Adjusting their bronchodilator therapy to control their symptoms [2004]

Patients at risk of having an exacerbation of COPD should be given a course of antibiotic and corticosteroid tablets to keep at home for use as part of a self-management strategy. [2004]

The appropriate use of these tablets should be monitored. [2004]

Patients given self-management plans should be advised to contact a health-care professional if they do not improve. [2004]

Fitness for General Surgery

The ultimate clinical decision about whether or not to proceed with surgery should rest with a consultant anaesthetist and consultant surgeon taking account of the presence of comorbidities, the functional status of the patient, and the necessity of the surgery. [2004]

It is recommended that lung function should not be the only criterion used to assess patients with COPD before surgery. Composite assessment tools such as the American Society of Anesthesiologists (ASA) scoring system are the best predictors of risk. [2004]

If time permits, the medical management of the patient should be optimised prior to surgery, and this might include undertaking a course of pulmonary rehabilitation. [2004]

Follow-up of Patients with COPD

Follow-up of all patients with COPD should include:

Highlighting the diagnosis of COPD in the case record and recording this using Read codes on a computer database

Recording the values of spirometric tests performed at diagnosis (both absolute and percent predicted)

Offering smoking cessation advice

Recording the opportunistic measurement of spirometric parameters (a loss of 500 ml or more over 5 years will select out those patients with rapidly progressing disease who may need specialist referral and investigation) [2004]

Patients with COPD should be reviewed at least once per year, or more frequently if indicated, and the review should cover the issues listed below in Table 6.

Table 6: Summary of Follow-up of Patients with COPD in Primary Care

Mild/Moderate/Severe (Stages 1 to 3)

Very Severe (Stage 4)

Frequency

At Least Annual

At Least Twice per Year

Clinical Assessments

Smoking status & desire to quit

Adequacy of symptom control

Breathlessness

Exercise tolerance

Estimated exacerbation frequency

Presence of complications

Effects of each drug treatment

Inhaler technique

Need for referral to specialist and therapy services

Need for pulmonary rehabilitation

Smoking status & desire to quit

Adequacy of symptom control

Breathlessness

Exercise tolerance

Estimated exacerbation frequency

Presence of cor pulmonale

Need for long-term oxygen therapy

Patient's nutritional state

Presence of depression

Effects of each drug treatment

Inhaler technique

Need for Social Services & Occupational Therapy input

Need for referral to specialist and therapy services

Need for pulmonary rehabilitation

Measurements to Make

FEV1 & FVC

Calculate BMI

MRC dyspnoea score

FEV1 & FVC

Calculate BMI

MRC dyspnoea score

SaO2

For most patients with stable severe disease, regular hospital review is not necessary, but there should be locally agreed mechanisms to allow rapid access to hospital assessment when necessary. [2004]

When patients with severe COPD are reviewed in primary care, they should be seen at least twice a year, and specific attention should be paid to the issues listed above in Table 6. [2004]

Patients with severe disease requiring interventions such as long-term noninvasive ventilation should be reviewed regularly by specialists. [2004]

Management of Exacerbations of COPD

The exacerbation section of this guideline was outside the scope of the 2010 update. However, the GDG was aware that some recommendations in the 'Oxygen therapy during exacerbations of COPD' section (section 1.3.6 in the original guideline) of the guideline were out of date, and these have been removed. Readers should refer to local protocols. Deleted recommendations can be found in appendix K of the full guideline.

Definition of an Exacerbation

An exacerbation is a sustained worsening of the patient's symptoms from their usual stable state which is beyond normal day-to-day variations, and is acute in onset. Commonly reported symptoms are worsening breathlessness, cough, increased sputum production and change in sputum colour. The change in these symptoms often necessitates a change in medication.

Assessment of Need for Hospital Treatment

Factors that should be used to assess the need to treat patients in hospital are listed in Table 7 of the original guideline document. [2004]

The diagnosis of an exacerbation is made clinically and does not depend on the results of investigations; however, in certain situations, investigations may assist in ensuring appropriate treatment is given. Different investigation strategies are required for patients managed in hospital (who will tend to have more severe exacerbations) and those managed in the community.

Primary Care

In patients with an exacerbation managed in primary care:

Sending sputum samples for culture is not recommended in routine practice

Pulse oximetry is of value if there are clinical features of a severe exacerbation. [2004]

Patients Referred to a Hospital

In all patients with an exacerbation referred to hospital:

A chest radiograph should be obtained

Arterial blood gas tensions should be measured and the inspired oxygen concentration recorded

An electrocardiogram (ECG) should be recorded (to exclude comorbidities)

A full blood count should be performed, and urea and electrolyte concentrations should be measured

A theophylline level should be measured in patients on theophylline therapy at admission

If sputum is purulent, a sample should be sent for microscopy and culture

Blood cultures should be taken if the patient is pyrexial [2004]

Hospital-at-home and Assisted Discharge Schemes

Hospital-at-home and assisted discharge schemes are safe and effective and should be used as an alternative way of managing patients with exacerbations of COPD who would otherwise need to be admitted or stay in hospital. [2004]

The multi-professional team required to operate these schemes should include allied health professionals with experience in managing patients with COPD, and may include nurses, physiotherapists, occupational therapists, and generic health workers. [2004]

There are currently insufficient data to make firm recommendations about which patients with an exacerbation are most suitable for hospital-at-home or early discharge. Patient selection should depend on the resources available and absence of factors associated with a worse prognosis (e.g., acidosis). [2004]

Patient's preferences about treatment at home or in hospital should be considered. [2004]

Pharmacological Management

Increased breathlessness is a common feature of an exacerbation of COPD. This is usually managed by taking increased doses of short-acting bronchodilators.

Delivery Systems for Inhaled Therapy During Exacerbations

Both nebulisers and hand-held inhalers can be used to administer inhaled therapy during exacerbations of COPD. [2004]

The choice of delivery system should reflect the dose of drug required, the ability of the patient to use the device, and the resources available to supervise the administration of the therapy. [2004]

Patients should be changed to hand-held inhalers as soon as their condition has stabilised because this may permit earlier discharge from hospital. [2004]

If a patient is hypercapnic or acidotic the nebuliser should be driven by compressed air, not oxygen (to avoid worsening hypercapnia). If oxygen therapy is needed, it should be administered simultaneously by nasal cannulae. [2004]

The driving gas for nebulised therapy should always be specified in the prescription. [2004]

Systemic Corticosteroids

In the absence of significant contraindications, oral corticosteroids should be used, in conjunction with other therapies, in all patients admitted to hospital with an exacerbation of COPD. [2004]

In the absence of significant contraindications, oral corticosteroids should be considered in patients managed in the community who have an exacerbation with a significant increase in breathlessness which interferes with daily activities. [2004]

Patients requiring corticosteroid therapy should be encouraged to present early to get maximum benefits (see Recommendations 122-126 in the original guideline document [full version]). [2004]

Prednisolone 30 mg orally should be prescribed for 7 to 14 days. [2004]

It is recommended that a course of corticosteroid treatment should not be longer than 14 days as there is no advantage in prolonged therapy. [2004]

For guidance on stopping oral corticosteroid therapy it is recommended that clinicians refer to the British National Formulary section 6.3.2. [2004]

Osteoporosis prophylaxis should be considered in patients requiring frequent courses of oral corticosteroids. [2004]

Patients should be made aware of the optimum duration of treatment and the adverse effects of prolonged therapy. [2004]

Patients, particularly those discharged from hospital, should be given clear instructions about why, when, and how to stop their corticosteroid treatment. [2004]

Antibiotics

Antibiotics should be used to treat exacerbations of COPD associated with a history of more purulent sputum. [2004]

Patients with exacerbations without more purulent sputum do not need antibiotic therapy unless there is consolidation on a chest radiograph or clinical signs of pneumonia. [2004]

Initial empirical treatment should be an aminopenicillin, a macrolide, or a tetracycline. When initiating empirical antibiotic treatment, prescribers should always take account of any guidance issued by their local microbiologists. [2004]

When sputum has been sent for culture, the appropriateness of antibiotic treatment should be checked against laboratory culture and sensitivities when they become available. [2004]

Theophylline and Other Methylxanthines

Intravenous theophylline should only be used as an adjunct to the management of exacerbations of COPD if there is an inadequate response to nebulised bronchodilators. [2004]

Care should be taken when using intravenous theophylline because of interactions with other drugs and potential toxicity if the patient has been on oral theophylline. [2004]

Theophylline levels should be monitored within 24 hours of starting treatment and subsequently as frequently as indicated by the clinical circumstances. [2004]

Respiratory Stimulants

It is recommended that doxapram is used only when noninvasive ventilation is either unavailable or considered inappropriate. [2004]

Oxygen Therapy during Exacerbations of COPD

The exacerbation section of this guideline was outside the scope of the 2010 update. However the GDG was aware that some recommendations in this section of the guideline were out of date, and these have been removed. Readers should refer to local protocols. Deleted recommendations can be found in appendix K of the full guideline.

The oxygen saturation should be measured in patients with an exacerbation of COPD, if there are no facilities to measure arterial blood gases. [2004]

If necessary, oxygen should be given to keep the SaO2 within the individualized target range. [2004, amended 2010]

Pulse oximeters should be available to all health-care professionals managing patients with exacerbations of COPD, and they should be trained in their use. Clinicians should be aware that pulse oximetry gives no information about the PCO2 or pH. [2004]

When the patient arrives at hospital, arterial blood gases should be measured and the inspired oxygen concentration noted in all patients with an exacerbation of COPD. Arterial blood gas measurements should be repeated regularly, according to the response to treatment. [2004]

Noninvasive Ventilation (NIV) and COPD Exacerbations

NIV should be used as the treatment of choice for persistent hypercapnic ventilatory failure during exacerbations despite optimal medical therapy. [2004]

It is recommended that NIV should be delivered in a dedicated setting with staff who have been trained in its application, who are experienced in its use, and who are aware of its limitations. [2004]

When patients are started on NIV, there should be a clear plan covering what to do in the event of deterioration and ceilings of therapy should be agreed. [2004]

Invasive Ventilation and Intensive Care

Patients with exacerbations of COPD should receive treatment on intensive care units, including invasive ventilation when this is thought to be necessary. [2004]

During exacerbations of COPD, functional status, BMI, requirement for oxygen when stable, comorbidities, and previous admissions to intensive care units should be considered, in addition to age and FEV1, when assessing suitability for intubation and ventilation. Neither age nor FEV1 should be used in isolation when assessing suitability. [2004]

NIV should be considered for patients who are slow to wean from invasive ventilation. [2004]

Respiratory Physiotherapy and Exacerbations

Physiotherapy using positive expiratory pressure masks should be considered for selected patients with exacerbations of COPD, to help with clearing sputum. [2004]

Monitoring Recovery from an Exacerbation

Patients' recovery should be monitored by regular clinical assessment of their symptoms and observation of their functional capacity. [2004]

Pulse oximetry should be used to monitor the recovery of patients with nonhypercapnic, nonacidotic respiratory failure. [2004]

Intermittent arterial blood gas measurements should be used to monitor the recovery of patients with respiratory failure who are hypercapnic or acidotic, until they are stable. [2004]

Daily monitoring of peak expiratory flow (PEF) or FEV1 should not be performed routinely to monitor recovery from an exacerbation because the magnitude of changes is small compared with the variability of the measurement. [2004]

Discharge Planning

Spirometry should be measured in all patients before discharge. [2004]

Patients should be reestablished on their optimal maintenance bronchodilator therapy before discharge. [2004]

Patients who have had an episode of respiratory failure should have satisfactory oximetry or arterial blood gas results before discharge. [2004]

All aspects of the routine care that patients receive (including appropriateness and risk of side effects) should be assessed before discharge. [2004]

Patients (or home carers) should be given appropriate information to enable them to fully understand the correct use of medications, including oxygen, before discharge. [2004]

Arrangements for follow-up and home care (e.g., visiting nurse, oxygen delivery, referral for other support) should be made before discharge. [2004]

Before the patient is discharged, the patient, family and physician should be confident that he or she can manage successfully. When there is remaining doubt a formal activities of daily living assessment may be helpful. [2004]

Clinical Algorithm(s)

The following clinical algorithms are provided in the appendices of the original guideline document:

Qualifying Statements

Qualifying Statements

This guidance represents the view of National Institute for Health and Clinical Excellence (NICE), which was arrived at after careful consideration of the evidence available. Healthcare professionals are expected to take it fully into account when exercising their clinical judgment. However, the guidance does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer, and informed by the summary of product characteristics of any drugs they are considering.

While every effort has been made to ensure the accuracy of the information contained within this publication, the publisher can give no guarantee for information about drug dosage and application thereof contained in this book. In every individual case the respective user must check current indications and accuracy by consulting other pharmaceutical literature and following the guidelines laid down by the manufacturers of specific products and the relevant authorities in the country in which they are practising.

Healthcare providers need to use clinical judgement, knowledge and expertise when deciding whether it is appropriate to apply guidelines. The recommendations cited here are a guide and may not be appropriate for use in all situations. The decision to adopt any of the recommendations cited here must be made by the practitioner in light of individual patient circumstances, the wishes of the patient, clinical expertise and resources.

The following recommendations have been identified as priorities for implementation. (Note that the order of the key priorities given here is arbitrary and does not reflect their relative importance. The reader should refer to the original recommendations for further detail.)

Diagnose COPD

A diagnosis of chronic obstructive pulmonary disease (COPD) should be considered in patients over the age of 35 who have a risk factor (generally smoking) and who present with exertional breathlessness, chronic cough, regular sputum production, frequent winter "bronchitis" or wheeze. [2004]

The presence of airflow obstruction should be confirmed by performing post-bronchodilator* spirometry. All health professionals involved in the care of people with COPD should have access to spirometry and be competent in the interpretation of the results. [2004] [*added 2010]

Stop Smoking

Encouraging patients with COPD to stop smoking is one of the most important components of their management. All COPD patients still smoking, regardless of age, should be encouraged to stop, and offered help to do so, at every opportunity. [2004]

Promote Effective Inhaled Therapy

In people with stable COPD who remain breathless or have exacerbations despite use of short-acting bronchodilators as required, offer the following as maintenance therapy:

If FEV1 <50% predicted: either LABA with an inhaled corticosteroid (ICS) in a combination inhaler, or LAMA. [new 2010]

Offer LAMA in addition to LABA+ICS to people with COPD who remain breathless or have exacerbations despite taking LABA+ICS, irrespective of their FEV1. [new 2010]

Provide Pulmonary Rehabilitation for All Who Need It

Pulmonary rehabilitation should be made available to all appropriate people with COPD including those who have had a recent hospitalisation for an acute exacerbation. [new 2010]

Use Non-invasive Ventilation

Non-invasive ventilation (NIV) should be used as the treatment of choice for persistent hypercapnic ventilatory failure during exacerbations not responding to medical therapy. It should be delivered by staff trained in its application, experienced in its use and aware of its limitations.

When patients are started on NIV, there should be a clear plan covering what to do in the event of deterioration and ceilings of therapy should be agreed. [2004]

Manage Exacerbations

The frequency of exacerbations should be reduced by appropriate use of inhaled corticosteroids and bronchodilators, and vaccinations. [2004]

The impact of exacerbations should be minimised by:

Giving self-management advice on responding promptly to the symptoms of an exacerbation

All group members made a formal Declaration of Interests at the start of the guideline development and provided updates throughout the process. The National Clinical Guideline Centre for Acute and Chronic Conditions (NCGC-ACC) and the Group Chair monitored these.

The guidelines manual 2007. London (UK): National Institute for Health and Clinical Excellence; 2007 April. Electronic copies: Available in PDF from the NICE Web site.

Patient Resources

The following is available:

Chronic obstructive pulmonary disease: Understanding NICE guidance. Information for people with chronic obstructive pulmonary disease, their families and carers, and the public. National Institute for Health and Clinical Excellence (NICE), 2010 Jun. 16 p. Electronic copies: Available from the National Institute for Health and Clinical Excellence (NICE) Web site. Also available in Welsh from the NICE Web site.

Please note: This patient information is intended to provide health professionals with information to share with their patients to help them better understand their health and their diagnosed disorders. By providing access to this patient information, it is not the intention of NGC to provide specific medical advice for particular patients. Rather we urge patients and their representatives to review this material and then to consult with a licensed health professional for evaluation of treatment options suitable for them as well as for diagnosis and answers to their personal medical questions. This patient information has been derived and prepared from a guideline for health care professionals included on NGC by the authors or publishers of that original guideline. The patient information is not reviewed by NGC to establish whether or not it accurately reflects the original guideline's content.

NGC Status

This NGC summary was completed by ECRI on July 12, 2004. The information was verified by the guideline developer on November 29, 2004. This summary was updated by ECRI on December 5, 2005 following the U.S. Food and Drug Administration (FDA) advisory on long-acting beta2-adrenergic agonists (LABA). This summary was updated by ECRI on November 21, 2006 following the FDA advisory on Tamiflu. This summary was updated by ECRI Institute on November 6, 2007, following the U.S. Food and Drug Administration advisory on Antidepressant drugs. This summary was updated by ECRI Institute on March 10, 2008 following the U.S. Food and Drug Administration (FDA) advisory on Tamiflu (oseltamivir phosphate). This summary was updated by ECRI Institute on April 9, 2008 following the U.S. Food and Drug Administration (FDA) advisory on Relenza (zanamivir). This summary was updated by ECRI Institute on May 1, 2009 following the U.S. Food and Drug Administration advisory on antiepileptic drugs. This summary was updated by ECRI Institute on July 20, 2009 following the U.S. Food and Drug Administration advisory on Varenicline and Bupropion. The information was reaffirmed by the guideline developer in March 2008 and updated by ECRI Institute on March 31, 2010. This NGC summary was updated by ECRI Institute on December 9, 2010. This summary was updated by ECRI Institute on July 15, 2011 following the U.S. Food and Drug Administration advisory on Chantix (varenicline). This summary was updated by ECRI Institute on January 14, 2013 following the revised U.S. Food and Drug Administration advisory on Chantix (varenicline). This summary was updated by ECRI Institute on April 8, 2015 following the U.S. Food and Drug Administration advisory on Chantix (varenicline).

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